EndoRings™ - Clinical Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.
研究概览
简要总结
The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure.
详细描述
The EndoAid Ltd. EndoRings is used during endoscopy procedures. The EndoRings is a short silicon rubber tube with flexible circular wings that attaches to the distal end of the endoscope to facilitate endoscopic therapy.
The EndoRings is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following ETO sterilization and is single use only.
Indications for Use:
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any subject who meets all of the following criteria may be included in this study:
- •Subject between the ages of 18 and 70
- •The patient is undergoing colonoscopy for screening, or for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- •Written informed consent must be available before enrollment in the trial
- •For women with childbearing potential, adequate contraception
排除标准
- •Any subject who meets any of the following criteria will not be included in this study:
- •Patients with a history of colonic resection;
- •Patients with inflammatory bowel disease;
- •Patients with a personal history of polyposis syndrome;
- •Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- •Patients with diverticulitis or toxic megacolon;
- •Patients with a history of radiation therapy to abdomen or pelvis;
- •Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
研究组 & 干预措施
Colonoscopy procedure with the EndoRings
Colonoscopy procedure using an add-on device (EndoRings) that is attached to the distal tip of the endoscope
干预措施: EndoRings (Device)
结局指标
主要结局
The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.
时间窗: 24 hours post procedure
次要结局
- 3. Procedure time.(During procedure)
- 7. Patient satisfactory.(During procedure)
- 1. Incidence of complications (number of complications)(24 hours post procedure)
- 4. Ease of scope insertion, advancement and withdrawal.(During procedure)
- 2. Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.(24 hours post procedure)
- 5. Ability to center the scope inside the gastrointestinal tract.(During procedure)
- 6. Subjective evaluation of the additional area screened by the physician.(During procedure)